Downstream Operations Scientist

University of Delaware

Equal Employment Opportunity Statement

The University of Delaware is an Equal Opportunity Employer which encourages applications from Minority Group Members, Women,
Individuals with Disabilities and Veterans. The University's Notice of Non-Discrimination can be found at http://www.udel.edu/aboutus/legalnotices.html

Job No: 502528

Work Type: Staff

Location: Newark, DE

Categories: Research & Laboratory

Pay Grade: 33E

Context of the Job:

NIIMBL (the National Institute for Innovation in Manufacturing
Biopharmaceuticals) is the largest industry-led public-private partnership dedicated to biopharmaceutical manufacturing innovation with participation from well-over 200 companies, government agencies, and other partners collectively innovating manufacturing approaches. As part of these activities, NIIMBL is home to a technical operations team that works collaboratively with scientists from across the biopharmaceutical manufacturing industry including manufacturers, suppliers, and government agencies. The
Downstream Operations Scientist is responsible for leading downstream purification unit operations in NIIMBL’s continuous mAb purification process that is part of a Process Intensification program. The work will involve 21CFR58 compliant downstream operations and data analysis, including utilizing automation systems. The scientist will also collaborate with bioreactor specialists and an analytical team, and have access to state-of-the-art knowledge from across the industry and government in guiding the work.

NIIMBL’s extensive portfolio of research, development, demonstration, and innovation activities is funded by federal, private, state, and other sources with the parent sponsoring government agency being the National Institute of Standards and
Technology (NIST). NIIMBL is also a member of the Manufacturing USA network of institutes, a multi-billion dollar investment by the federal government to advance United States competitiveness in advanced manufacturing innovation. Institutionally at the
University of Delaware, NIIMBL reports to the Vice President for
Research, Scholarship & Innovation.

Among other activities, NIIMBL executes technical projects that advance the readiness levels of relevant technologies, assays, and methods. The scopes of scientific projects generally include many organizations as partners and collaborators such as scientists from several large and small companies, a scientist from a federal agency, and a scientist from a university. Many of these projects will be hosted at the University of Delaware in a state-of-the-art laboratory facility purpose-built for such studies. These projects will involve a diverse set of technologies and approaches and address drug substance, drug product, and analytical needs by the industry appropriate to several types of biopharmaceuticals:
therapeutic antibodies and proteins , gene therapy vectors, vaccines, antibody-drug conjugates, bispecific antibodies, and cell therapies, among others.

Major Responsibilities

• Demonstrate NIIMBL’s Core Values in daily conduct and ensures

all decisions, actions, and teamwork practices align with the organization’s Business Principles.

• Serve as a lead technical scientist on multiple projects

involving downstream purification unit operations for the manufacture of industrially relevant products and related activities.

• Evaluate and introduce new technologies and analytical tools to

existing processes.

• Adhere to 21CFR58 GxP guidelines in execution of work.
• Set-up, operate, troubleshoot, maintain, and clean downstream

bioprocessing equipment.

• Use manufacturing experience to identify process parameters and

define their setpoints.

• Perform DoE studies to confirm the impact of process parameters

on impurity levels, product recovery, and potency.

• Characterize performance of existing purification and

formulation unit operations, including column chromatography (e.g.,
ProA, SEC, CEX, AEX), filtration, TFF, and bulk filling.

• Develop new filtration unit operations such as tangential-flow

filtration (TFF), virus filtration, and depth filtration.

• Develop new chromatography unit operations, from screening and

characterization to optimization and initial scale-up.

• Optimize buffer compositions to improve the stability and

solubility of target molecules.

• Collaborate with an analytical team to adapt and troubleshoot

research analytical methods such as HPLC, SDS-PAGE, enzyme activity and endotoxin assays to quantify yield, activity, and purity at various stages of the manufacturing process.

• Document all work and analyses in an electronic lab notebook.

Perform tracking and trend analysis of method performance.

• Analyze process performance trends, perform statistical data

analysis, and present data to teams.

• Partner with Informatics Infrastructure team on deploying

structured data capture systems.

• Draft and revise SOPs and batch records.
• Maintain detailed documentation of lab activities and

tabulation of data.

• Compile data generated to present and discuss at team

meetings.

• Author, review and edit technical reports and manuscripts

intended for publication.

• Stay current with relevant technologies and scientific

literature.

• Perform other job-related duties as assigned.

Qualifications:

• A Masters and 5+ years or PhD and 2+ years in chemical

engineering or relevant life science discipline.

• Industrially relevant downstream purification experience is

required with preference for experience in a 21CFR58-compliant GxP environment.

• Hands-on experience with a range of downstream unit operations

and control systems, experience with DeltaV preferred.

• Operates chromatography skids and other bioprocess equipment

for purification of industrially relevant materials.

• Knowledge of biotech manufacturing process and equipment

including depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations.

• Possess a contribution mindset fueled by an inner drive to take

initiative without being directed.

• Excellent interpersonal and managing skills with the desire to

work collaboratively and effectively in a team environment.

• Ability to demonstrate effective leadership through

communication, respect, influence, persuasion, and trust.

• Excellent problem solving and critical thinking skills.
• Excellent writing, communication, and presentation skills.
• Strong MS Excel, PowerPoint, and Word skills. Microsoft Project

skills.

• Excellent organization and planning skills.
• Strong attention to detail and ability to adhere to standards

procedures.

• Ability to function in a rapidly changing environment.

Notice of Non-Discrimination and Equal Opportunity

The University of Delaware does not discriminate against any person on the basis of race, color, national origin, sex, gender identity or expression, sexual orientation, genetic information, marital status, disability, religion, age, veteran status or any other characteristic protected by applicable law in its employment, educational programs and activities, admissions policies, and scholarship and loan programs as required by Title IX of the
Educational Amendments of 1972, the Americans with Disabilities Act of 1990, Section 504 of the Rehabilitation Act of 1973, Title VI and VII of the Civil Rights Act of 1964, and other applicable statutes and University policies. The University of Delaware also prohibits unlawful harassment including sexual harassment and sexual violence.

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